In accordance with the EC Regulation 1223/2009, which imposes the use of the UNI EN ISO 22716 for the production of cosmetics under the standards of good manufacturing practice, Di Renzo Regulatory Affairs provides a technical staff consisting of auditors and technicians able to evaluate, both from the operational standpoint and the documentation, the quality and compliance with cosmetic GMP by companies.
The change that underlies the EC Regulation 1223/2009 consists of the complete responsibility of the company that places the product on the market, even for those technical aspects that were previously only the preserve of the manufacturer.
According to this innovation the company that owns the trademark, even if it only carries out a commercial activity, is required to verify, through inspections, that the manufacturer follows Good Manufacturing Practices as required for the cosmetics sector, and to attach the report of that audit to the technical documentation of the cosmetic product (PIF – Product Information File).
The law no longer considers it sufficient to attach to the technical dossier the declaration by the manufacturer certifying compliance with GMP. It is now necessary for the owner of the trademark to carry out an inspection at the production sites, unless they do not have a certificate in accordance with ISO 22716 issued by an accredited body.
The consultancy offered by Di Renzo Regulatory Affairs verifies that the procedures required by ISO 22716 are effectively implemented by the manufacturer.